Libre 2 With Real-Time Alerts/Alarms Approved in EU

Abbott announced it received CE Mark for the FreeStyle Libre 2, which now includes optional real-time alerts/alarms. Abbott said it will price Libre 2 at parity to the original Libre System and the company is planning an EU launch in the coming weeks. Abbott did not disclose its regulatory/commercial plans for the US; however, this remains a large market opportunity for the company and is anticipated in the coming months. Importantly, during Abbott’s EASD symposium, it was shown that the Libre 2 CE Mark approval includes the updated algorithm for overall 14-day accuracy at 9.5% MARD (US is 9.4%). Below, FENIX provides the key highlights and potential implications to the CGM market.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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